ADVERSE REACTIONS

6.1 - Clinical Trials Experience

USE IN SPECIAL POPULATIONS

Section 8.4 - Pediatric Use

the clinical relevance of spot fecal fat testing has not been demonstrated. Adverse reactions….

Section 8.5 - Geriatric Use

July 2010

ADVERSE REACTIONS

Clinical Trials Experience

The short-term safety of Creon was assessed in clinical trials conducted in 103 patients with exocrine pancreatic insufficiency (EPI): 49 patients with EPI due to cystic fibrosis (CF) and 25 patients with EPI due to chronic pancreatitis or pancreatectomy were treated with Creon.

Cystic Fibrosis- Studies 1 and 2 were randomized, double-blind, placebo-controlled, crossover studies of 49 patients, ages 7 to 43 years, with EPI due to CF. Study 1 included 32 patients ages 12 to 43 years and Study 2 included 17 patients ages 7 to 11 years. In these studies, patients were randomized to receive Creon at a dose of 4,000 lipase units/g fat ingested per day or matching placebo for 5 to 6 days of treatment, followed by crossover to the alternate treatment for an additional 5 to 6 days. The mean exposure to CREON during these studies was 5 days.

USE IN SPECIFIC POPULATIONS

Pediatric Use

The short-term safety and effectiveness of Creon were assessed in two randomized, double-blind, placebo controlled, crossover studies of 49 patients with exocrine pancreatic insufficiency due to cystic fibrosis, 25 of whom were pediatric patients, Study 1 included 8 adolescents between 12 and 17 years of age. Study 2 included 17 children between 7 and 11 years of age. The safety and efficacy in pediatric patients in these studies were similar to adult patients